Shim Chi Young, Seo Jiwon, Kim Young Jin, Lee Seung Hyun, De Caterina Raffaele, Lee Sak, Hong Geu-Ru
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
J Thorac Cardiovasc Surg. 2023 Jan;165(1):58-67.e4. doi: 10.1016/j.jtcvs.2021.01.127. Epub 2021 Feb 9.
Early warfarin anticoagulation is recommended in patients undergoing surgical bioprosthetic valve implantation or valve repair. It is unclear whether non-vitamin K antagonist oral anticoagulants can be a full alternative to warfarin. This study aimed to compare efficacy and safety of edoxaban with warfarin in patients early after surgical bioprosthetic valve implantation or valve repair.
The Explore the Efficacy and Safety of Edoxaban in Patients after Heart Valve Repair or Bioprosthetic Valve Replacement study was a prospective, randomized (1:1), open-label, clinical trial conducted from December 2017 to September 2019. Patients were randomly assigned to receive edoxaban (60 mg or 30 mg once daily) or warfarin for the first 3 months after surgical bioprosthetic valve implantation or valve repair. The primary efficacy outcome was a composite of death, clinical thromboembolic events, or asymptomatic intracardiac thrombosis. The primary safety outcome was the occurrence of major bleeding.
Of 220 participants, 218 (109 per group) were included in the modified intention-to-treat analysis. The primary efficacy outcome occurred in 4 patients (3.7%) taking warfarin and none taking edoxaban (risk difference, -0.0367; 95% confidence interval, -0.0720 to -0.0014; P < .001 for noninferiority). The primary safety outcome occurred in 1 patient (0.9%) taking warfarin and 3 patients (2.8%) taking edoxaban (risk difference, 0.0183; 95% confidence interval, -0.0172 to 0.0539; P = .013 for noninferiority).
Edoxaban is noninferior to warfarin for preventing thromboembolism and is potentially comparable for risk of major bleeding during the first 3 months after surgical bioprosthetic valve implantation or valve repair.
对于接受生物人工瓣膜植入术或瓣膜修复术的患者，推荐早期使用华法林进行抗凝治疗。目前尚不清楚非维生素K拮抗剂口服抗凝药是否能完全替代华法林。本研究旨在比较依度沙班与华法林在生物人工瓣膜植入术或瓣膜修复术后早期患者中的疗效和安全性。
“探索依度沙班在心脏瓣膜修复或生物人工瓣膜置换术后患者中的疗效和安全性”研究是一项前瞻性、随机（1:1）、开放标签的临床试验，于2017年12月至2019年9月进行。患者在生物人工瓣膜植入术或瓣膜修复术后的前3个月被随机分配接受依度沙班（60mg或30mg每日一次）或华法林治疗。主要疗效结局为死亡、临床血栓栓塞事件或无症状心内血栓形成的复合结局。主要安全结局为大出血的发生。
220名参与者中，218名（每组109名）纳入改良意向性分析。服用华法林的4名患者（3.7%）出现主要疗效结局，而服用依度沙班的患者无一人出现（风险差异，-0.0367；95%置信区间，-0.0720至-0.0014；非劣效性P<0.001）。服用华法林的1名患者（0.9%）出现主要安全结局，服用依度沙班的3名患者（2.8%）出现（风险差异，0.0183；95%置信区间，-0.0172至0.0539；非劣效性P=0.013）。
在生物人工瓣膜植入术或瓣膜修复术后的前3个月，依度沙班在预防血栓栓塞方面不劣于华法林，且在大出血风险方面可能相当。
